Newron Pharmaceuticals S.p.A. Conference Call April 16, 2008 12:00 CET Luca Benatti, CEO Ravi Anand, CMO Marco Caremi, VP Strategic Marketing Disclaimer • This document has been prepared by Newron Pharmaceuticals S.p.A. (“Newron”), to the best of its knowledge and belief, solely for your information and is strictly confidential. This document is not to be (i) used for any purpose other than in connection with the purpose of this presentation, (ii) reproduced or published, (iii) circulated to any person other than to whom it has been provided at this presentation. • The information contained in this document has been provided by Newron, unless otherwise noted. 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Any person who is not a relevant person should not act or rely on this document or any of its contents. • This document is not a prospectus pursuant to art. 652a of the Swiss Code of Obligations or art. 32 et seq. of the SWX Swiss Exchange Listing Rules. • By accepting this document, you acknowledge and agree to each of the foregoing notices. 2 Conference call, April 16, 2008 Agenda • Company overview • Ralfinamide results in peripheral neuropathic pain • Nerve compression and entrapment market • Ralfinamide results in post-surgical (dental) pain • Summary 3 Conference call, April 16, 2008 Overview • Focus on global, growing CNS market, addressing diseases with significant unmet medical needs • Late-stage validated clinical pipeline • Proven drug discovery expertise • Management with proven track record of bringing CNS drugs to market (Comtan™, Cabaser™, Exelon™, Clozaril™) • Total funds raised: € 137M • Listed on main segment of SWX Swiss Exchange (NWRN) • Strong analyst coverage • Pipeline expanded through acquisition of neuro-inflammation company Hunter Fleming 4 Conference call, April 16, 2008 Recent Milestones • Commercial settlement with Purdue – option to Purdue patents √ • Positive ralfinamide Phase II data in neuropathic pain √ • IND approved for Ralfinamide in neuropathic pain √ • Start/completion of enrolment of ralfinamide Phase II study in post surgical (dental) pain √ • EU use patent for ralfinamide in migraine √ • Positive safinamide 18 months Phase III data in PD √ • Start of safinamide Phase III MOTION trial (Merck Serono) √ • Extension of safinamide patent protection: EPO intention-to-grant letter √ • Start of development of NW-3509 √ • Opening of clinical development facility in Basel √ • Carlos de Sousa appointed as CBO √ • Dr. Hans-Joachim Lohrisch appointed non-executive member of BoD √ • Acquisition of Hunter Fleming √ 5 Conference call, April 16, 2008 Post Acquisition of Hunter-Fleming: CNS focus maintained, pipeline broadened 6 Conference call, April 16, 2008 Ralfinamide Results in peripheral NP Ralfinamide - an innovative therapeutic agent for neuropathic and inflammatory pain • Oral use, small molecule, new chemical class • Linear kinetics, excellent “drugability” • Blocks ion channel subtypes, incl. Nav 1.7 • Long-lasting anti-allodynic and anti-hyperalgesic effects in models of neuropathic pain • No development of tolerance on chronic dosing • No need of titration • One of the largest pharmaceutical market: analgesics ~23b$ 8 Conference call, April 16, 2008 MTD study 001 Key results Ralfinamide MTD Study 001 • A phase II, – multicenter, – pilot, – randomized, – ascending dose, – double-blind, – placebo-controlled, – dose titration study to determine • safety, • maximum tolerated dose and • preliminary evidence of efficacy of ralfinamide in the range of 80-320 mg/day in patients with neuropathic pain 10 Conference call, April 16, 2008 Study design • Indication: Mixed Neuropathic Pain Syndromes • Randomization: Unequal; ralfinamide vs placebo 2:1 • 272 patients • Treatment duration: 8 weeks • Countries: Austria; India; Italy; Poland; Czech-R; UK • Primary efficacy measure: VAS score 11 Conference call, April 16, 2008 Patient and analysis population Ralfinamide (n=177) Placebo (n=95) 80-320 mg/day N % N % Total randomized 177 95 ITT Set All Patients randomised with at least 172 97.2% 95 100% one post-baseline efficacy value. Modified Population (MPOP) All Patients randomised after study re- 129 72.9% 77 75.7% start. 12 Conference call, April 16, 2008 Demographic data and types of Neuropathic Pain (NP) Ralfinamide Placebo Age in years: mean (SD) 58.1 (11.43) 56.7 (9.76) Gender (male): number (%) 94 (53.4) 52 (54.7) Body weight in kg: mean (SD) 75.6 (14.76) 76.5 (15.8) Race number (%) • Caucasian 140 (79.5) 73 (76.8) • Asian 36 (20.5) 21 (22.1) PNP Diagnosis • NCET 59 (33.4%) 38 (41.1%) • Diabetic neuropathy 44 (24.9%) 21 (22.1%) • Ischemic nerve disease 10 (5.6%) 5 (5.3%) • Traumatic neuropathy 27 (15.2%) 10 (10.6%) • PHN 13 (7.3%) 7 (7.4%) 24 (13.6%) 13 (13.7%) • Other NCET: Nerve Compression or Entrapment 13 Conference call, April 16, 2008 Study Disposition Screened n=386 Treatment Groups Ralfinamide (n=177) Placebo (n=95) Premature Termination N= 56 (31.8%) N= 22 (23.2%) • Sponsor action1 16 (9%) 5 (5.3%) • Protocol deviation 7 (4%) 3 (3.2% • Lack of efficacy 4 (2.3%) 1 (1.1%) • Consent withdrawn 14 (7.9%) 5 (5.3%) • Loss to follow up/other 3 (1.7%) 3 (3.2%) • SAEs 1 (0.6%) 1 (1.1%) 11 (6.2%) 4 (4.2%) • Due to AEs (not rated serious) 1= treatment was terminated in these patients by the sponsor due to toxicology finding; study was reinitiated later after resolution of the issue 14 Conference call, April 16, 2008 Most Frequent Adverse Events (≥5%) Adverse Events (Preferred Terms) Ralfinamide (n= 177) Placebo (n= 95) Headache 13 (7.3%) 10 (10.5%) Nausea 9 (5.1%) 10 (10.5%) Dyspepsia 5 (2.8%) 7 (7.4%) Abdominal Pain 8 (4.5%) 5 [1 SAE] (5.3%) CPK increase 4 (2.3%) 5 (5.3%) Dizziness 6 (3.4%) 8 (8.4%) Pruritus 3 (1.7) 5 (5.3%) Retinal disorder 4 (2.3%) 5 (5.3%) Vomiting 5 (2.8%) 5 (5.3%) 15 Conference call, April 16, 2008 Results of Ocular Examination 1 1 Change from Baseline to Ralfinamide Placebo Endpoint Patients with 1 New Abnormality 13 (11.5%) 7 (10.4%) • Visual acuity 1 (0.9%) 0 • Visual fields left eye 10 (9.1%) 2 (3%) • Visual fields right eye 7 (6.4%) 4 (6.1%) • Fundoscopy left eye 1 (0.9%) 2 (3%) • Fundoscopy right eye 0 2 (3%) 1 = 113 patients in the ralfinamide and 67 in the placebo group underwent ocular examination 16 Conference call, April 16, 2008 Differences in the Mean Change for the VAS and Likert ALL-LOCF MPOP-LOCF Ralfinamide Placebo Ralfinamide Placebo (n=169) (n=92) (n=126) (n=74) VAS Change Vs Ancova Baseline -18.1 (24.54) -12.5 (20.13) -20.1 (25.74) -10.4 (20.62) (±SD) Treatment Difference* -5.2 (-11.0, 0.5) -8.1 (-14.9, -1.4) (95% CI) p-value 0.075 0.0187 Likert (Pain) Change Vs Ancova Baseline -1.7 (2.09) -0.97 (1.85) -1.8 (2.22) -0.84 (1.96) (±SD) Treatment Difference* -0.7 (-1.18, -0.17) -0.93 (-1.5, -0.3) (95% CI) p-value 0.008 0.0026 Daily Diary Change Vs Sleep Baseline -1.27 (2.06) -0.67 (2.09) -1.5 (2.14) -0.44 (2.13) Ancova (±SD) Treatment Difference* -0.57 (-1.06, -0.08) -0.95 (-1.5, -0.37) (95% CI) p-value 0.024 0.0014 Daily Diary Change Vs Activity Baseline -1.3 (2.37) -0.8 (2.04) -1.55 (2.51) -0.72 (2.17) Ancova (±SD) Treatment Difference* -0.49 (-1.04, 0.06) -0.76 (-1.4, -0.10) (95% CI) p-value 0.079 0.024 * Difference in LS Mean 17 Conference call, April 16, 2008 Differences in the Responder Rate Analyses for the VAS and Likert ALL-LOCF MPOP-LOCF Ralfinamide Placebo Ralfinamide Placebo (n=169) (n=92) (n=126) (n=74) VAS Responder Rate 50% n (%) 48 (28.4) 16 (17.4) 40 (31.7) 12 (16.2) Risk Difference (95% CI) 11.0 (0.7, 21.3) 15.5 (3.8, 27.2) p-value 0.048 0.016 Likert (Pain) Responder Rate 50% n (%) 43 (25.7) 13 (14.0) 34 (27.4) 11 (14.7) Risk Difference (95% CI) 11.8 (2.1, 21.4) 12.8 (1.5, 24.0) p-value 0.027 0.037 Daily Diary Responder